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A Phase I/II Open-label Study of Eltrombopag for the Prevention of Chemotherapy Induced Thrombocytopenia (CIT) in Subjects With Advanced Soft Tissue and Bone Sarcomas Receiving Gemcitabine and Docetaxel Chemotherapy


Phase 1/Phase 2
18 Years
82 Years
Not Enrolling
Both
Sarcoma, Soft Tissue, Osteosarcoma, Neoplasms, Connective and Soft Tissue

Thank you

Trial Information

A Phase I/II Open-label Study of Eltrombopag for the Prevention of Chemotherapy Induced Thrombocytopenia (CIT) in Subjects With Advanced Soft Tissue and Bone Sarcomas Receiving Gemcitabine and Docetaxel Chemotherapy


The combination chemotherapy regimen of gemcitabine and docetaxel has become an increasingly
used treatment choice for subjects with advanced sarcomas. The regimen has shown activity
in first and second line for subjects with metastatic uterine leiomyosarcoma,
relapsed/refractory pediatric sarcomas, and improved progression-free survival and overall
survival in persons with metastatic sarcoma when compared to gemcitabine alone. The regimen
has additionally been recognized as a treatment option for subjects with advanced sarcoma.

Chemotherapy-induced toxicity in the blood such as low platelet level is a common and often
therapy-limiting side effect of treatment.

There are two phases in this study. The purpose of the Phase I study is to determine the
recommended dose of eltrombopag. The purpose of the Phase II study is to determine the
safety, tolerability, and efficacy (how well the drug works) of eltrombopag in subjects who
are receiving gemcitabine and docetaxel chemotherapy.

Eltrombopag (Promacta) is an FDA approved drug for the treatment of chronic idiopathic
thrombocytopenic purpura (ITP)- a condition of having an abnormally low platelet count.
Eltrombopag is now being further investigated for other thrombocytopenic (low
platelet)disorders.

Participants will take the assigned dose of eltrombopag once a day starting five days before
each cycle of chemotherapy and for 5 days after chemotherapy. Eltrombopag is not taken on
the day of chemotherapy. Eltrombopag is taken orally.


Inclusion Criteria:



- Metastatic soft tissue or bone sarcoma

- 18 years of age or older

- Adequate blood counts

- Adequate kidney and liver function

- At least 1 but no more than 3 prior systemic therapy regimens for this cancer

- Good performance status - able to carry out work of a light or sedentary nature

Exclusion Criteria:

- Pre-existing hear disease such as congestive heart failure, or arrhythmia known to
increase the risk of thromboembolic events (blood clots)

- Blood clot in the last 6 months, known clotting problem or platelet disorder

- History of brain cancer

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Tolerated Eltrombopag Dose

Outcome Description:

Measured in milligrams (mg). The primary objective of the phase I study is to determine the recommended phase II dose. The maximum dose is the dose of which less than 2 of 6 patients experienced an unacceptable event/side effect

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Richard F Riedel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Food and Drug Administration

Study ID:

Pro00032798

NCT ID:

NCT01491594

Start Date:

April 2012

Completion Date:

March 2013

Related Keywords:

  • Sarcoma, Soft Tissue
  • Osteosarcoma
  • Neoplasms, Connective and Soft Tissue
  • Metastatic sarcoma
  • Bone sarcoma
  • Neoplasms
  • Osteosarcoma
  • Thrombocytopenia
  • Neoplasms, Connective and Soft Tissue
  • Sarcoma

Name

Location

Duke Cancer CenterDurham, North Carolina  27710